Kornimate/medical-research-clean huggingface dataset:
remote activity monitored by fitbit charge 3 in investigating daily step and sleep data in participants with head and neck cancer undergoing radiation therapy

Conditions: Head and Neck Carcinoma

Summary: this pilot trial studies remote activity monitored by fitbit charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. a wearable remote activity tracking device, such as the fitbit charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.

primary objectives: i. determine compliance with remote activity monitoring (ram) in patients receiving radiotherapy (rt) or chemoradiotherapy (crt) for head and neck cancer (hnc). secondary objectives: i. evaluate feasibility of recruitment to the remote activity monitoring pilot (ramp). ii. investigate patient acceptability of ram. iii. evaluate compliance with electronic patient-reported outcomes (epros) in this patient population. iv. estimate the change in average daily steps associated with a one-unit change in health score as collected on epro analysis (analyze associations between ram data and epros). v. investigate correlations among step data, quality of life (qol), and emergency room (er) visits/hospitalizations.

Eligibility criteria:
inclusion criteria: * subjects have head and neck cancer as defined in history and physical * patients are eligible to be treated with rt or crt and plan to start treatment * patients are capable of giving informed consent * patients must be able to read and/or to speak english * patients who are 18 years of age or older * women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation ct planning scan exclusion criteria: * patients who cannot read or speak english * patients who are not candidates for rt/crt treatment. * women of childbearing potential who are pregnant or breastfeeding
efficacy, feasibility, and acceptability of the dest-act: trauma-focused acceptance and commitment therapy program

Conditions: Trauma and Stressor Related Disorders

Summary: the aim of this study is to develop a post-earthquake, trauma-focused acceptance and commitment therapy (act)-based psychosocial intervention program (dest-act) and to examine its effectiveness, feasibility, and acceptability of this program in enhancing life satisfaction and psychological flexibility in individuals exposed to earthquake trauma. in this regard, the main hypothesis is that the dest-act psychosocial intervention program is effective, feasible, and acceptable among individuals exposed to earthquake trauma, including both primary and secondary outcomes of the program.

this quantitative, randomized controlled trial involves two groups and includes a pre-test and repeated post-tests. the study aims to assess the effectiveness, feasibility, and acceptability of the developed dest-act program in addressing post-traumatic stress disorder, psychological flexibility, life satisfaction, values-based living, and depression-anxiety-stress levels in individuals affected by the february 6, 2023 earthquake. participants will be randomly assigned to experimental and control groups in a 1:1 ratio using an internet-based block randomization program. the dest-act psychosocial intervention program consists of a 4-session online intervention supported by self-help materials. each session in the 4-week program is held once a week for 50 minutes. the main hypotheses are: * the intervention group will demonstrate a significant decrease in post traumatic stress disorder (ptsd) and depression-anxiety-stress levels compared to the control group. * the intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to the control group. * the intervention group will demonstrate a significant decrease in ptsd and depression-anxiety-stress levels compared to baseline measures. * the intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to baseline measures.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * being present in cities such as kahramanmaras, gaziantep, hatay, adiyaman, or malatya during the earthquake on february 6, where destruction occurred * being literate * being able to have an online interview with the therapist * having sub-threshold ptsd or ptsd exclusion criteria: * being in other cities at the time of the earthquake and not being exposed to the earthquake * having visual and/or hearing problems * having any psychotic disorder, experiencing an active mood episode, or having conditions such as intellectual disability or dementia that would prevent participation in therapy * starting a new psychiatric treatment during the research period or having a change in medication or dosage within the last 3 months.
potassium-titanyl phosphate (ktp) laser vs ktp laser and ivermectin cream for facial rosacea

Conditions: Rosacea

Summary: rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes and scalp. rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa and phymatosa. treatments depend on the type and include topical and systemic antibiotics, azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as intense pulsed light (ipl) and laser therapies. for treatment of telangiectasia and redness, laser and ipl therapies are the first choice. vascular lasers, such as pulsed dye lasers (pdl) and potassium-titanyl phosphate (ktp) lasers as well as ipl, have demonstrated good efficacy in reduction of erythema and telangiectasias in patients with rosacea. however, these treatments are expensive and mostly not covered by the health insurance. therefore, for patients it is important to receive the maximal effect and improvement after each single laser session. ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect as well as an antiparasitic effect on demodex mite. the latter is playing an important pathogenetic role in rosacea. this randomized controlled study aims to compare the effect of ktp laser in combination with ivermectin 1% cream vs ktp laser alone in patients with facial rosacea.


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i-iv * presence of facial erythematous rosacea or mild papulopustular rosacea with permanent erythema * informed consent signed exclusion criteria: * history of adverse events related to ktp laser therapy * pregnant or breastfeeding women * intention to become pregnant during the course of the study * history of intolerance or allergic reaction to ivermectin 1% cream or one of the ingredients * ongoing treatment for skin cancer * ongoing treatment with strong inhibitors of p-glycoprotein (p-gp) and cyp3a4 (e.g., itraconazole, voriconazole, posaconazole, clarithromycin, cobicistat) * ongoing treatment with substances with a narrow therapeutic range whose excretion depends substantially on p-gp (e.g. digoxin, ciclosporin) * inability to understand the study content

Keywords: rosacea laser ivermectin
sleep and cytokines during acute diverticulitis

Conditions: Acute Diverticulitis

Summary: the purpose of this study is to investigate sleep disturbances during acute uncomplicated diverticulitis by polysomnography. the investigators hypothesis is the inflammation causes rem(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.

an increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. sleep is important both in health and disease processes and can affect recovery, morbidity and mortality. studies have been done on sleep disturbances after major and minor gi-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis. this study will investigate sleep architecture by polysomnography and inflammation by levels of pro inflammatory cytokines in plasma. following methods will be applied device: polysomnograph - embla titanium (natus medical incorporated, usa) procedure: plasma cytokines (il-2, il-6 and tnf(tumor necrosis factor-alfa) procedure: plasma crp(c reactive protein) and leukocytes

Eligibility criteria:
inclusion criteria: * ct-verified diverticulitis patients managed by antibiotic treatment at herlev hospital * pain and fever occurred less than 72 hours prior to the admission * asa (american society of anesthesiologists) score i to iii exclusion criteria: * surgical intervention needed * complicated diverticulitis * complications in relation to diverticulitis * pain and fever occurred more than 72 hours prior to the admission * in anticoagulant treatment and heart rate control treatment * known autoimmune disease * known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea * shift-work or jetlag * daily use of opioid, psychopharmaca, opioids or anxiolytics (including hypnotics) * known psychiatry conditions in treatment with psychopharmaca * daily alcohol intake of more than 5 units or drug abuse * missing written consent * diabetes mellitus * predicted bad compliance * pregnant or breast-feeding * urine or fecal incontinence * severe kidney disease * current cancer
promotion of healthy eating behaviors in type 2 diabetes patients

Conditions: Healthy Lifestyle; Diabetes

Summary: intervention designed to promote healthy eating in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age * type 2 diabetes * poor dietary habits exclusion criteria: * micro and macro-vascular complications * poor glycemic control * food allergy
diet and migraine study

Conditions: Migraine; Obesity

Summary: the purpose of this study is to look at two different diets (a low carbohydrate diet and a low fat diet) for migraine prevention in overweight or obese persons with migraine. the overall aim is to test the theory that diet will improve migraine frequency and that such improvements will be associated with favorable changes in body weight, inflammation, and heart health.

obesity is a risk factor for migraine. further, in the past decade multiple lines of research have substantiated the presence of migraine headaches as a risk factor for cvd (eg. stroke). migraineurs have also been demonstrated to have abnormal insulin responses, higher lipids and endothelial dysfunction. limited data suggests a low fat diet may be of benefit in reducing migraine frequency; no studies have examined the efficacy of a low carbohydrate (ie. low glycemic) diet for migraine prevention in adults.. none of these studies examined the effects and potential mechanisms of such diet programs on cv health, body composition, and the inflammatory cascade in migraineurs. this 3 -month study addresses the efficacy and potential mechanisms of two different diets, (a low carbohydrate diet and a low fat diet) for migraine prevention in a clinical cohort of overweight or obese persons with migraine. the overall aim is to test the hypothesis that each behavioral intervention will improve migraine frequency and that such improvements will be associated with favorable changes in body composition, inflammation, and cv parameters. hypothesis 1.1 the mean monthly migraine frequency will be decreased in those who maintain a low-fat diet or low-carbohydrate diet for 3 months as compared to controls. hypothesis 1.2 participants randomized to the diets will demonstrate favorable changes in body composition (eg. decrease in adipose tissue volume on magnetic resonance imaging (mri) and body fat on dexa), inflammatory markers (eg. decrease in adipocytokine levels), and cv parameters (eg. improved cholesterol panel, glucose levels and markers of arterial stiffness) as compared to controls.

Eligibility criteria:
inclusion criteria: * overweight or obese (bmi between 25 and 42) * women * \>18 years and \< 50 years old * migraine meeting ichd criteria for at least 6 months prior to screening * headache frequency documented \> 2 and \< 10 headache days per month * bp inclusion criteria are sbp \<160 or dbp \<100 mm hg exclusion criteria: * hypocaloric diet (must be weight stable for prior 3 months) * self-report of alcohol or substance abuse in the past year or current treatment * type 1 or 2 diabetes

Keywords: migraine obesity low fat diet low carbohydrate diet
fsl2 post approval study for pediatric and young adults patients

Conditions: Diabete Mellitus

Summary: this is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the freestyle libre 2 flash glucose monitoring system when used to manage diabetes in pediatric and young adult patient populations.

approximately 550 pediatric and young adult subjects aged 4-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. subjects and/or their caregivers will utilize he freestyle libre 2 flash glucose monitoring system for managing diabetes for 6 months. subjects and/or their caregivers will maintain a diary/log book of adverse events experienced during the duration of the study. assessment of adverse events will occur via self reporting at each monthly visit and/or phone call.

Eligibility criteria:
inclusion criteria: 1. subject must be 4 - 30 years of age. 2. subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment. 3. subject is currently using self monitoring of blood glucose (smbg) for managing their diabetes. 4. subject has completed participation in clinical study adc-us-pms-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention. 5. subject and/or caregiver must be able to read and understand english. 6. in the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 7. subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate. exclusion criteria: 8. subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months. 9. subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 10. subject is known to be pregnant or is attempting to become pregnant at the time of enrollment. 11. subject is on dialysis at the time of enrollment. 12. subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. 13. subject currently is participating in another clinical trial. 14. subject is unsuitable for participation due to any other cause as determined by the investigator.
flexible v/s rigid cystoscopy in men with urinary tract infection

Conditions: Lower Urinary Tract Symptoms

Summary: the objective of this study is to perform a randomized study, comparing the outcomes of the above two types of cystoscopy in terms of discomfort experienced by the patient, while undergoing the procedure.

cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic tool in urology.compared with flexible endoscopes, rigid instruments offer better image quality, a wider lumen of the working channel, improved irrigant flow and superior handiness. however, flexible cystoscopes provide more options for patient positioning, enable smooth passage over an elevated bladder neck or median lobe, facilitate full inspection of the bladder because of their movable tip and, what is most important is it significantly improve patient comfort(patient can be positioned in any comfortable position).

Eligibility criteria:
inclusion criteria: * patients with lower urinary tract symptoms exclusion criteria: * patients with suprapubic catheter * history of radical prostatectomy or cystoprostatectomy * clinical evidence of urethral stricture, prostatitis * patients with bacterial growth on urine culture

Keywords: rigid cystoscopy flexible cystosocpy uti bph
metformin plus megestrol acetate as a fertility-sparing treatment in patients with atypical endometrial hyperplasia

Conditions: Atypical Endometrial Hyperplasia

Summary: to verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(aeh).

whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(aeh) is still not clear. our previous finding from subgroup analysis in a phase ii randomized controlled trial showed that 39.6% of aeh patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. this trial aim to fully testify the effect of metformin in fertility-sparing treatment for aeh patients with adequate sample size.

Eligibility criteria:
inclusion criteria: 1. 18-45 years old; 2. pathologically diagnosed with aeh for the first time; 3. desire to preserve their fertility; 4. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (mri), enhanced computed tomography (ct) or transvaginal ultrasonography (tvus); 5. no contraindication for metformin, megestrol acetate or pregnancy; 6. no hormone or metformin treatment within 6 months before entering the trial; 7. not pregnant when participating in the trial; 8. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial. exclusion criteria: patients who had one or more of the following conditions: 1. allergy history or contraindications for megestrol acetate or metformin; 2. pregnant when initiating the study; 3. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney); 4. high risk of thrombosis; 5. recurrent aeh; 6. endometrial cancer; 7. other malignancy history.
a study to select the dose and evaluate the effectiveness and safety of the drug refralon®, tablets, 1 mg for long-term use to prevent recurrence of atrial fibrillation/flutter after terminating its persistent form

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. efficacy and safety of refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.


Eligibility criteria:
inclusion criteria: * persistent form of af/afl lasting 7 days - 1 year (including patients who have previously undergone ineffective catheter or surgical ablation of af or afl and patients with a pacemaker or implanted cardioverter-defibrillator (icd)); * basic rhythm - af and/or afl according to the results of 12-lead ecg at randomization (visit 2); * left ventricular ejection fraction (lvef) \>40% according to the simpson method; exclusion criteria: * intake of class ia, ic and class iii antiarrhythmic drugs less than 7 days (for amiodarone less than 60 days) before the study drug intake; * history of myocardial infarction or other structural heart disease; * qt prolongation over 500 ms.

Keywords: refralon cavutilide niferidil class iii antiarrhythmic drug new russian drug atrial fibrillation (af) tablet atrial flutter (afl)
a study testing the effectiveness of nesiritide in patients with acute decompensated heart failure

Conditions: Heart Decompensation

Summary: the purpose of this study is to find out if nesiritide (a human b-type natriuretic peptide/hbnp) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

acute decompensated heart failure (adhf) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. adhf is a condition in which the heart cannot perform the necessary circulation of blood through the body. this is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo \[does not contain study drug\]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. the study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through day 30. the study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. the patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). the patients assigned to the placebo group will receive matching placebo bolus and infusion. the bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Eligibility criteria:
inclusion criteria: hospitalized for the management of acute decompensated heart failure (adhf) or diagnosed with adhf within 48 hours after being hospitalized for another reason; diagnosis of adhf is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity. exclusion criteria: at high risk for hypotension (low blood pressure); acute coronary syndrome as primary diagnosis; history of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; previous enrollment in a nesiritide study; persistent, uncontrolled hypertension (sbp \[systolic blood pressure\] \>180 mmhg).

Keywords: heart decompensation dyspnea heart failure nesiritide decompensated adhf